Class II — Bausch & Lomb, Inc.
| Recalling firm | Bausch & Lomb Incorporated |
|---|---|
| Registered facility | View this company's 10 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond). Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction. Therefore Bausch & Lomb is proposing a Field Correction to provide customer purchasing product from April 30, 2012 to June 20, 2016 with the current operating instruction. |
| Product | Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient |
| Quantity | 2487 units Domestic (USA), 1,211 units Foreign (outside USA) |
| Distribution | Worldwide Distribution - US Nationwide |
| Initiated | 2016-10-12 |
| Classified | 2017-01-09 |
| Terminated | 2017-07-14 |
| Recall number | Z-0983-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bausch & Lomb, Inc. (Z-0983-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75915/
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